DURABLE MEDICAL EQUIPMENT (DME) includes, but is not limited to, wheelchairs (manual and electric), hospital beds, traction equipment, canes, crutches, walkers, kidney machines, ventilators, oxygen, monitors, pressure mattresses, lifts, nebulizers, bili blankets and bili lights. Your CPAP device (or 'Continuous Positive Airway Pressure' machine) is considered “durable medical equipment (DME)”, which means that it is covered under Medicare Part B.
Medicare Part B (Medical Insurance) covers medically necessary health care services or supplies needed to diagnose or treat an illness, injury, condition, disease, or its symptoms and that meet accepted standards of medicine.
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I recently had one or two clients ask about their CPAP machine. The machine or devices attached to the machine were defective and causing other illness or problems for them. They wanted to know what they could do about it. They mentioned that the machine had a recall on it but what could they do in the meantime? They needed their CPAP machine.
Well, in the meantime … I ran across this article. Please read and I included a link for the full article below.
In this article about the recall, the manufacturer is Philips Respironics, which may or may NOT be your machine. But the "view more button" below to the “Safety Communication” is a link to the U.S. Food and Drug Administration (FDA) with lots of information on the problem with these devices, the machines or models, and how to get help (either with this machine or other brands). Please share this newsletter with friends and family:
Respiratory Equipment Affected by Recent Phillips Respironics Recall:
On June 14, 2021 Philips Respironics, a major manufacturer of respiratory equipment issued a recall for several of its models of continuous positive airway pressure (CPAP) devices, respiratory assist devices (RADs), and ventilators covered by Medicare under the durable medical equipment (DME) benefit due to possible health risks. See the Safety Communication issued by the FDA.
Philips Respironics will repair or replace devices affected by this recall; it could take up to a year to complete these remediation tasks.
Supplier Responsibility:
You must help Medicare patients who rent or own devices affected by the recall and explain which items and services are covered and paid for related to this recall. You and your staff must understand the requirements if you furnished certain respiratory equipment subject to the recent recall under the Medicare Part B benefit for DME, including:
- Ventilators
- CPAP devices
- RADs
Ventilators:
If you are renting ventilators affected by this recall to patients enrolled under Medicare Part B, work with the patients and their physicians to identify and furnish appropriate alternative devices to use during the remediation period.
CPAP Devices and RADs:
If you rented CPAP devices or RADs affected by this recall to patients enrolled under Medicare Part B for less than 13 months of continuous use, work with the patients and their physicians to identify and furnish appropriate alternative devices for the remainder of the 13-month period of continuous use.
If you transferred title to CPAP devices or RADs affected by this recall to patients enrolled under Medicare Part B after 13-months of continuous use, and:
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They used it for the 5-year reasonable useful lifetime of the device, tell the patient they can get a replacement device if they haven’t already and if it’s still medically necessary.
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They used it for less than the 5-year reasonable useful lifetime of the device, help them register the device with Philips Respironics for repair or replacement. Furnish a replacement device as it may take Philips Respironics up to a year to repair or replace the device. Under federal regulations, you must replace the equipment at no charge to the Medicare Program or patient if the equipment doesn’t last for the entire 5-year reasonable useful lifetime.
If it’s difficult to get replacement CPAP devices or RADs for all of your patients, another supplier can furnish replacement devices while the Medicare patients wait for their devices to be repaired or replaced by the manufacturer if the new supplier does not charge your patients or the Medicare Program for the replacement devices. The supplier furnishing the substitute devices at no additional cost can bill and get paid for accessories used with the replacement devices.
